Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy
- Conditions
- Paralytic Ileus
- Interventions
- Drug: Oral/enteral placebo solutionDrug: Oral/enteral TJ-100 solution
- Registration Number
- NCT01607307
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.
- Detailed Description
Daikenchuto (TJ-100), a traditional Japanese herbal medicine, is used for prevention and treatment of postoperative ileus. TJ-100 extract powder (Tsumura \& Co., Tokyo, Japan) is manufactured as an aqueous extract containing 2.2 % Japanese pepper, 5.6 % processed ginger, 3.3 % ginseng, and 88.9 % maltose syrup powder. A recent randomized, parallel-group, double-blind, placebo-controlled, dose-response trial demonstrated that TJ-100 accelerates colonic transit time, particularly in the ascending colon. Given its potential actions in the intestinal tract, it seems reasonable to postulate that TJ-100 may play a role in improving and preventing bowel dysmotility. This study was designed to investigate the effect of TJ-100 on intestinal dysmotility and for the prevention of postoperative paralytic ileus in patients undergoing pancreaticoduodenectomy.
The primary endpoint is the incidence of postoperative paralytic ileus. Secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change in ratio of abdominal circumference, the incidence of postoperative complications, the length of hospital day, and the incidence of surgical site infection. Two hundred patients are required for the study (100 patients per group).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 220
- Patients with periampullary tumors (extrahepatic bile duct tumor, tumors of ampulla of Vater and duodenal tumor) and pancreatic tumors (pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, pancreatic endocrine tumor and pancreatic neuroendocrine tumor) of the head of the pancreas who are scheduled to undergo PD.
- Age of at least 20 years old at the time of registration.
- All patients provided written informed consent before initiation of study-related procedures.
- Clinically problematic cardiac disease.
- Liver cirrhosis or active hepatitis.
- Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.).
- Chronic renal failure requiring hemodialysis.
- Other malignant disease that can influence the adverse effect.
- Patients with tumors requiring resection of colon.
- Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history.
- Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants.
- Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration.
- Pregnant or lactating women.
- Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral/enteral placebo solution Oral/enteral placebo solution Oral/enteral placebo solution Oral/enteral TJ-100 solution Oral/enteral TJ-100 solution Oral/enteral TJ-100 solution
- Primary Outcome Measures
Name Time Method The duration until the first flatus after surgery. 14 days The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.
Incidence of postoperative paralytic ileus (including the duration of paralysis) 72 hours Delayed passage of first flatus for 72 hours (3.0 days) after surgery, or a postoperative condition that requires an intervention for the ileus. Every 12 hours is counted as 0.5 postoperative day and every 24 hours as 1.0 postoperative day.
- Secondary Outcome Measures
Name Time Method Abdominal pain and abdominal distention scores on the Visual Analogue Scale. 3 days Abdominal pain and abdominal distention scores on the Visual Analogue Scale on postoperative day 3.
The long term incidence of postoperative ileus after surgery. 2 years The follow-up investigation of the long term incidence of postoperative ileus is scheduled in two years after surgery.
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) 7 days QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) on postoperative day 7.
The incidence of postoperative complication. 14 days The incidence of postoperative complication based on Dindo's classification.
The incidence of surgical site infection. 30 days Intra-abdominal abscess was defined as intra-abdominal fluid collection with positive cultures identified by ultrasonography or computed tomography associated with persistent fever and elevations of white blood cell counts.
The change ratio of abdominal circumference. 3 days The change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery
The length of postoperative hospital day. 30 days Patients were discharged only when they fulfilled the criteria as follows: a return to preoperative activities of daily living, no deep-site infections, normal laboratory data, no drains, and the possibility for oral nutrition above the basal metabolism.
Trial Locations
- Locations (5)
Hiroshima University
🇯🇵Hiroshima, Japan
Shizuoka Cancer Center Hospital
🇯🇵Shizuoka, Japan
Wakayama Medical University
🇯🇵Wakayama, Japan
Nagoya University
🇯🇵Nagoya, Aichi, Japan
Osaka University
🇯🇵Suita, Osaka, Japan